Credentials
Experienced Practitioner:
– Over 45 years’ experience in biopharma and medical devices; most at an executive level.
– Experienced in sterile manufacture, complex pharmaceutical production and non-sterile products.
– Managed quality, regulatory, R&D, operations, customer service, and supply chain and compliance in Australia & New Zealand, Asia Pacific, Europe and the United States.
– Implemented quality management systems and compliance programs in Australia & New Zealand, Asia Pacific, Europe and United States.
Accomplished Manager:
– Past General Manger of a high-volume, specialized sterile facility in Australia.
– Past Vice President positions in the United States, Senior Director across Asia Pacific, Chief Operating Officer of a medical device company and Managing Director and Chief Executive Officer of a public biotech.
– Managed all technical areas of pharma and medical devices – Quality, Compliance, Integrity, R & D, Regulatory Affairs.
Industry Involvement:
– Lectured Good Manufacturing Practice to the Hanoi School of Pharmacy.
– Previous Advisor to the Australian Department of Industry & Resource on Biotechnology policies,
– Previous Committee member for
* AusBiotech the Australian Pharmaceutical Manufacturer’s Association
* West Australian Chamber of Commerce & Industry,- Previous member of:
* European Pharmaceutical Manufacturer’s Association Technical Committee, International Trade,
* International Federation Pharmaceutical Manufacturers & Associations Code revision committee,
* Medicines Australia Code of Conduct revision committee.
– Past Chairman of the Cosmetic & Pharmaceutical Special Interest Group of the Australian Society for Microbiology.
– Member of the Society of Corporate Compliance and Ethics; American Society of Quality and Health Care Compliance Association.
Peer Recognition:
– Recipient of the George Varkanis (Celgene ANZ) Leadership Award in 2018.
– Invited speaker at over twelve international conferences.
– Over 50 published articles on quality, compliance, ethics, training, reward & recognition, and integrity.
– Calvin is a certified International with the International Association of Professional Writers & Editors (IAPWE).